Treatment of Moderate to Severe Facial Acne Vulgaris

Phase 2 Study Randomized, Double-blind Study to Evaluate the Safety and Efficacy of 3 Doses of Doxycycline as Compared to Placebo in the Treatment of Moderate to Severe Facial Acne Vulgaris

Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline in non-inflammatory and total lesions of the active study medication to placebo will be evaluated.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Doxycycline 0.6 mg/kg/day; Drug: Doxycycline 1.2 mg/kg/day; Drug: Doxycycline 2.4 mg/kg/day; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 257
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91436
      • Warner Chilcott Investigational Site
    • Fremont, California, United States, 94538
      • Warner Chilcott Investigational Site
    • Los Angeles, California, United States, 90045
      • Warner Chilcott Investigational Site
    • Sacramento, California, United States, 95816
      • Warner Chilcott Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80210
      • Warner Chilcott Investigational Site
  • Florida
    • Miami, Florida, United States, 33175
      • Warner Chilcott Investigational Site
  • Georgia
    • Newnan, Georgia, United States, 30263
      • Warner Chilcott Investigational Site
    • Snellville, Georgia, United States, 30078
      • Warner Chilcott Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Warner Chilcott Investigational Site
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Warner Chilcott Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106-5239
      • Warner Chilcott Investigational Site
  • New York
    • Rochester, New York, United States, 14623
      • Warner Chilcott Investigational Site
  • North Carolina
    • Winston Salem, North Carolina, United States, 27103
      • Warner Chilcott Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Warner Chilcott Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • Warner Chilcott Investigational Site
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • Warner Chilcott Investigational Site
    • Fort Washington, Pennsylvania, United States, 19034
      • Warner Chilcott Investigational Site
  • Texas
    • Austin, Texas, United States, 78759
      • Warner Chilcott Investigational Site
    • College Station, Texas, United States, 77845
      • Warner Chilcott Investigational Site
    • Dallas, Texas, United States, 75246
      • Warner Chilcott Investigational Site
    • Houston, Texas, United States, 77056
      • Warner Chilcott Investigational Site
    • San Antonio, Texas, United States, 78229
      • Warner Chilcott Investigational Site
  • Washington
    • Spokane, Washington, United States, 99204
      • Warner Chilcott Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must be between 12 and 45 years of age.
• Has a diagnosis of moderate to severe facial acne vulgaris with no more than two nodules on the face

Exclusion Criteria:

• Is allergic to tetracycline-class antibiotics or to any ingredient in the study medication.
• Has a history of pseudomembranous colitis or antibiotic-associated colitis.
• Has a history of hepatitis or liver damage or renal impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo, 12 weeks
Experimental: Doxycyline 0.6 mg/kg/day; Doxycycline dosed at 40 mg/day to subjects of appropriate weights	Drug: Doxycycline 0.6 mg/kg/day; doxycycline 40 mg/day, oral, 12 weeks
Experimental: Doxycycline 1.2 mg/kg/day; Doxycycline dosed at 80 mg/day to subjects of appropriate weights	Drug: Doxycycline 1.2 mg/kg/day; doxycycline 80 mg/day, 12 weeks
Experimental: Doxycycline 2.4 mg/kg/day; Doxycycline dosed at 160 mg/day to subjects of appropriate weights	Drug: Doxycycline 2.4 mg/kg/day; doxycycline 160 mg/day, 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population	IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory & inflammatory lesions, no more than a few nodular lesions. Lower score improvement in score. Success=IGA decrease of at least 2 grades from baseline score.	Week 12
Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population	Change derived as Baseline evaluation minus the Week 12 evaluation. Thus a positive change reflects a reduction in lesion count. Inflammatory Lesion Count includes nodules, papules and pustules.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population	Noninflammatory Lesion Count includes open and closed comedones.	Baseline to Week 12
Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population	Total Lesion Count is the sum of inflammatory and noninflammatory lesions.	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Warner Chilcott
• Investigators: Study Director: Angelo Secci, MD, Warner Chilcott

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: January 25, 2008
• First Submitted That Met QC Criteria: January 25, 2008
• First Posted (Estimate): February 11, 2008

Study Record Updates

• Last Update Posted (Estimate): April 22, 2013
• Last Update Submitted That Met QC Criteria: April 15, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: PR-07907; WC2055